Trends and patterns of antibiotic using from 2014 to 2018 in stomatology hospitals of China.

OBJECTIVE: To analyze trends of antibiotic consumption and expenditure in Chinese stomatology hospitals between 2014 and 2018 with a longitudinal study design, and show the impacts of the comprehensive policy on dental antibiotic use in China. SUBJECT AND METHODS: Consumption was quantified as the number of daily defined doses (DDDs) and expenditure as the procurement costs, using medical institutions' drug procurement data from the Chinese Monitoring Network for Rational Use of Drugs. Descriptive statistics was employed and the compound annual growth rate (CAGR) was calculated to show the average annual growth rate. RESULTS: Between 2014 and 2018, overall antibiotic consumption increased from 842.6 thousand DDDs to 1376.7 thousand DDDs (p < 0.001) and expenditure increased from 11.6 million RMB to 20.9 million RMB (p < 0.001), where other ß-lactam antibacterials accounted for the largest proportion of total consumption (37.1%-50.1%) and expenditure (52.9%-66.6%), and also increase the largest (CAGR = 18.4%, p < 0.001). The proportion of oral antibiotics was nearly 9 times of parenteral antibiotics in consumption (CAGR = 0.3%, p = 0.023) and only 2 times in expenditure (CAGR = -1.7%, p = 0.112). The non-restricted group accounted for more than 90% of consumption (CAGR = 0.6%, p < 0.001). In 2018, oral first-generation cephalosporins (22.8%), oral imidazole derivatives (22.3%), and oral second-generation cephalosporins (19.2%) were the most frequently used antibiotic classification, while parenteral second-generation cephalosporins were top one (19.8%) for expenditure. At chemical substance levels, the consumption of oral cefradine ranked top one (21.4%) and parenteral cefuroxime accounted for the largest proportion of expenditure (14.5%) in 2018. Oral cefradine, oral metronidazole, and oral cefaclor were the top three frequently consumed antibiotics throughout the five years. CONCLUSIONS: Despite the potential antibiotic overuse, the comprehensive antibiotic stewardship regulations of China got a satisfactory and better performance in dental practices. More effort is needed to establish more explicit guidelines to improve antibiotic stewardship, such as priority recommending amoxicillin and its derivatives for endodontic infections.

Association of potentially inappropriate medications with prognosis among older patients with non-small cell lung cancer.

BACKGROUND: Potentially inappropriate medications (PIMs) are common among older adults with cancer, but their association with overall survival (OS) among non-small cell lung cancer (NSCLC) patients remains unclear. This study aimed to investigate the association between the use of PIMs and OS in patients with NSCLC. METHODS: In this cohort study, we included patients ≥ 65 years with newly diagnosed NSCLC from January 2014 to December 2020. Potentially inappropriate medication (PIM) is defined by the Beers criteria of 2019 at baseline and within six months following the initiation of systemic therapy. Multivariable Cox regression model was built to assess the association between PIMs and overall survival (OS). RESULTS: We finally included 338 patients with a median follow-up for OS of 1777 days. The prevalence of patients receiving at least one PIM was 39.9% (135/338) and 61.2% (71/116) at baseline and after systemic therapy, respectively. The most important factor associated with PIM use was the number of prescribed medications (P < 0.001). Baseline PIM use and PIM after systemic therapy were significantly associated with inferior OS (476 days vs. 844 days, P = 0.044; and 633 days vs. 1600 days, P = 0.007; respectively). In multivariable analysis, both baseline PIM use and PIM after systemic therapy were independent predictors of poor prognosis (adjusted HR, 1.33; 95% CI, 1.01-1.75; P = 0.041; and adjusted HR, 1.86; 95% CI, 1.11-3.14; P = 0.020; respectively). CONCLUSIONS: PIMs are prevalent among older patients with NSCLC and are independent predictors of NSCLC prognosis. There is an urgent need for clinicians to conduct medication reconciliation and appropriate deprescribing for this population, especially for patients with multiple PIMs.

[Guidelines for economic evaluation of post-marketing Chinese patent medicine].

With the premise of drug safety and effectiveness, pharmacoeconomic evaluation can provide optimal solutions for diversified decision-making application scenarios from different research perspectives while maximizing the rational utilization of existing healthcare resources. Chinese patent medicine is an essential component of pharmaceutical utilization in China and a significant part of healthcare expenditure in China. However, the economic evaluation of post-marketing Chinese patent medicine is lacking. These evaluations often lack standardization, exhibit varying quality, and are unable to effectively support healthcare decisions, indicating a need for improvement in overall quality. Given this situation, this project has gathered leading experts from China and has strictly adhered to the requirements of the group standards set by the China Association of Traditional Chinese Medicine in developing Guidelines for economic evaluation of post-marketing Chinese patent medicine, aiming to provide methodological guidance for the post-market pharmacoeconomic evaluation of Chinese patent medicine, enhancing the standardization of pharmacoeconomic evaluations of Chinese patent medicine and the scientific validity of research results, and thereby elevating the overall quality of pharmacoeconomic evaluations for post-marketing Chinese patent medicine. The guidelines adhere to the framework provided by relevant laws and regulations in China and technical guidance documents. It is based on guidance from traditional Chinese medicine(TCM) theories, focusing on the unique characteristics of TCM. It covers various aspects of pharmacoeconomic evaluation, including fundamental principles, research topic selection, research question definition, study design type selection, cost identification and measurement, health outcomes, and evaluation methods. The guidelines offer methodological recommendations and decision guidance to address common issues and challenges in the pharmacoeconomic evaluation of post-marketing Chinese patent medicine.

Use of suboptimal control arms in randomized clinical trials of investigational cancer drugs in China, 2016-2021: An observational study.

BACKGROUND: The use of suboptimal controls in randomized trials of new cancer drugs can produce potentially unreliable clinical efficacy results over the current standard of care and expose patients to substandard therapy. We aim to investigate the proportion of randomized trials of investigational cancer drugs that used a suboptimal control arm and the number of trial participants at risk of exposure to suboptimal treatments in China. The association between the use of a suboptimal control and concluding statistical significance on the primary endpoint was also examined. METHODS AND FINDINGS: This observational study included randomized controlled trials (RCTs) of cancer drugs that were authorized by specific Chinese institutional review boards between 2016 and 2021, supporting investigational new drug applications of these drugs in China. The proportion of trials that used a suboptimal control arm and the total number of trial participants at risk of exposure to suboptimal treatments were calculated. In a randomized trial for a specific condition, a comparator was deemed suboptimal if it was not recommended by clinical guidelines published in priori or if there existed a regimen with a higher level of recommendation for the indication. The final sample included 453 Phase II/III and Phase III randomized oncology trials. Overall, 60 trials (13.2%) adopted a suboptimal control arm. Among them, 58.3% (35/60) used comparators that were not recommended by a prior guideline for the indication. The cumulative number of trial participants at risk of exposure to suboptimal treatments totaled 18,610 by the end of 2021, contributing 15.1% to the total number of enrollees of all sampled RCTs in this study. After adjusting for the year of ethical approval, region of participant recruitment, line of therapy, and cancer site, second-line therapies (adjusted odds ratio [aOR] = 2.7, 95%CI [1.2, 5.9]), adjuvant therapies (aOR = 8.9, 95% CI [3.4, 23.1]), maintenance therapies (aOR = 5.2, 95% CI [1.6, 17.0]), and trials recruiting participants in China only (aOR = 4.1, 95% CI [2.1, 8.0]) were more likely to adopt a suboptimal control. For the 105 trials with publicly available results, no statistically significant difference was observed between the use of a suboptimal control and concluding positive on the primary endpoint (100.0% [12/12] versus 83.9% [78/93], p = 0.208). The main limitation of this study is its reliance on clinical guidelines that could vary across cancer types and time in assessing the quality of the control groups. CONCLUSIONS: In this study, over one-eighth of randomized trials of cancer drugs registered to apply for regulatory approval in China used a suboptimal comparator. Our results highlight the necessity to refine the design of randomized trials to generate optimal clinical evidence for new cancer therapies.

Inpatient antibacterial use trends and patterns, China, 2013-2021.

Objective: To analyse trends and patterns in inpatient antibacterial use in China's tertiary and secondary hospitals between 2013 and 2021. Methods: The analysis involved quarterly data from hospitals covered by China's Center for Antibacterial Surveillance. We obtained information on hospital characteristics (e.g. province, a de-identified hospital code, hospital level and inpatient days) and antibacterial characteristics (e.g. generic name, drug classification, dosage, administration route and usage volume). We quantified antibacterial use as the number of daily defined doses per 100 patient-days. The analysis took into account the World Health Organization's (WHO's) Access, Watch, Reserve classification of antibiotics. Findings: Between 2013 and 2021, overall antibacterial use in inpatients decreased significantly from 48.8 to 38.0 daily defined doses per 100 patient-days (P < 0.001). In 2021, the variation between provinces was almost twofold: 29.1 daily defined doses per 100 patient-days in Qinghai versus 55.3 in Tibet. The most-used antibacterials in both tertiary and secondary hospitals throughout the study period were third-generation cephalosporins, which comprised around one third of total antibacterial use. Carbapenems entered the list of most-used antibacterial classifications in 2015. The most frequently used antibacterials in WHO's classification belonged to the Watch group: usage increased significantly from 61.3% (29.9/48.8) in 2013 to 64.1% (24.4/38.0) in 2021 (P < 0.001). Conclusion: Antibacterial use in inpatients decreased significantly during the study period. However, the rising proportion of last-resort antibacterials used is concerning, as is the large gap between the proportion of antibacterials used belonging to the Access group and WHO's global target of no less than 60%.

Potentially inappropriate medications among older patients with Parkinson's disease: a cross-sectional analysis of a national health insurance database in China.

BACKGROUND: With the rapid aging trend of China's population, the issue of drug rational use in older adults has become more and more prominent. Parkinson's disease (PD) is the one of the most common age-related neurodegenerative disorders. Pharmaceutical treatment plays a cardinal role in alleviating motor and non-motor symptoms to improve the quality of life of patients with PD. Patients with PD have complex medical needs yet little is known about the use of potentially inappropriate medications (PIM) among them in China. We quantify the prevalence of PIM use and identify its predictors among older persons with PD in China. METHODS: We conducted a cross-sectional analysis using a national representative database of all medical insurance beneficiaries across China, extracting records of ambulatory visits of older adults with PD between 2015 and 2017. Beneficiaries aged 65 and above were eligible for inclusion. The prevalence of patients exposed to overall PIMs and PIMs related to motor and cognitive impairment was calculated based on Beers Criteria 2015 version. Potential predictors of PIM concerning patients' characteristics were estimated using multivariate logistic regression. RESULTS: A total of 14,452 older adults with PD were included. In total, 8,356 (57.8%) patients received at least one PIM; 2,464 (17.1%) patients received at least one motor-impairing PIM and 6,201 (42.9%) patients received at least one cognition-impairing PIM. The prevalence of overall PIM use was higher in patients of older age group (54.7% [65-74] vs. 59.5% [75-84; OR, 1.22; 95% CI, 1.14-1.31] vs.65.5% [≥ 85; OR, 1.58; 95% CI, 1.38-1.80) and females (61.4% [female] vs. 55.0% [males; OR, 0.77; 95% CI, 0.72-0.82). CONCLUSIONS: Prescribing PIMs for older adults with PD was common in China, especially for females and older age groups, yet younger patients were more inclined to be prescribed with motor or cognition-impaired PIMs. Our findings represent a clear target awaiting multidimensional efforts to promote the rational prescribing of medications for this vulnerable population.

Childhood cancer drugs in China: An overview and comparison of regulatory approvals in China and the United States.

Different from less developed countries, 80% of children with cancers in the United States are cured. Traditional chemotherapy drugs are the mainstay of therapies; new targeted medications have become available recently. Using publicly available data, we created a database of cancer drugs with paediatric malignancy indications approved by 31 October 2020 in China and the United States. We compared numbers, type, indications and listing on the World Health Organization Model List of Essential Medicines for Children (WHO EMLc) between the two countries, assessed the correlation between paediatric indications and cancer incidences, and described evidence supporting approvals of targeted medications in the two settings. Our study showed that by 31 October 2020, 31 and 39 cancer drugs available in China and the United States were approved for use in children, corresponding to 137 and 102 paediatric cancer indications, respectively. About half of these drugs (17 in China and 18 in the United States) were listed on the WHO EMLc. The correlation between indications and burden of disease was higher in the United States (r = 0.68) than China (r = 0.59). More traditional chemotherapy drugs were approved in China (n = 27) than the United States (n = 19). Of 20 targeted childhood anticancer medicines approved in the United States, mainly on the basis of single arm trials (27/32 indications, 84.4%), only four were approved for paediatric indications in China, at a median of 2.8 years after US Food and Drug Administration approval. A harmonised, evidence-based regulatory framework is needed to ensure approvals of needed, safe and efficacious childhood cancer drugs across the world.

Health technology assessment-informed pricing negotiation in China: higher negotiated price for more effective targeted anticancer medicines?

BACKGROUND: In China, health technology assessment (HTA) has recently been adopted in pricing negotiation for medicine listing in the National Reimbursement Drug List. At present, how HTA is applied to inform the decision-making process remains underreported. In order to explore how the adoption of HTA was translated into listing and price negotiation results in light of the confidential nature of the negotiating process, this study aimed to compare the negotiated price and the clinical benefit of selected targeted anticancer medicines (TAMs) involved in the 2019 negotiation. MAIN TEXT: Among 16 TAMs successfully negotiated, only four TAMs representing four indication groups had appropriate reference medicines for comparison and were, therefore, included in the analysis. The price and clinical benefit of the four TAMs were compared against one or two reference medicines with the same initial indications. The sales prices for nine TAMs before and after the negotiation were extracted from the centralized medication procurement system. Clinical benefits were evaluated based on evidence from published articles and clinical guidelines. The results suggested that, despite the application of HTA, both rational and irrational decisions had been made about the reimbursement of TAMs in the 2019 negotiation, warranting further investigation. CONCLUSION: While the development and adoption of HTA has seen significant progress in China, actions are needed to ensure that the adoption of HTA is effectively applied in decisions on the reimbursement of medicines.

Review of social networks of professionals in healthcare settings-where are we and what else is needed?

BACKGROUND: Social Network Analysis (SNA) demonstrates great potential in exploring health professional relationships and improving care delivery, but there is no comprehensive overview of its utilization in healthcare settings. This review aims to provide an overview of the current state of knowledge regarding the use of SNA in understanding health professional relationships in different countries. METHODS: We conducted an umbrella review by searching eight academic databases and grey literature up to April 30, 2021, enhanced by citation searches. We completed study selection, data extraction and quality assessment using predetermined criteria. The information abstracted from the reviews was synthesized quantitatively, qualitatively and narratively. RESULTS: Thirteen reviews were included in this review, yielding 330 empirical studies. The degree of overlaps of empirical studies across included reviews was low (4.3 %), indicating a high diversity of included reviews and the necessity of this umbrella review. Evidence from low- and middle-income countries (LMIC), particularly Asian countries, was limited. The earliest review was published in 2010 and the latest in 2019. Six reviews focused on the construction or description of professional networks and seven reviews reported factors or influences of professional networks. We synthesized existing literature on social networks of health care professionals in the light of (i) theoretical frameworks, (ii) study design and data collection, (iii) network nodes, measures and analysis, and (iv) factors of professional networks and related outcomes. From the perspective of methodology, evidence lies mainly in cross-sectional study design and electronic data, especially administrative data showing "patient-sharing" relationships, which has become the dominant data collection method. The results about the impact of health professional networks on health-related consequences were often contradicting and not truly comparable. CONCLUSIONS: Methodological limitations, inconsistent findings, and lack of evidence from LMIC imply an urgent need for further investigations. The potential for broader utilization of SNA among providers remains largely untapped and the findings of this review may contain important value for building optimal healthcare delivery networks. PROSPERO REGISTRATION NUMBER: The protocol was published and registered with PROSPERO, the International Prospective Register of Systematic Reviews (CRD42020205996).

The impact of smoking status on the progression-free survival of non-small cell lung cancer patients receiving molecularly target therapy or immunotherapy versus chemotherapy: A meta-analysis.

WHAT IS KNOWN AND OBJECTIVE: Smoking has a notable influence on the efficacy of medications for lung cancer. Previous studies illustrated the correlation between smoking and the efficacy of first-line Epidermal Growth Factor Receptors-Tyrosine Kinase Inhibitors (EGFR-TKIs). The benefit of smokers in immunotherapy was still controversial. Here, we investigated the impact of smoking on clinical outcomes of molecularly targeted therapies or immunotherapy in Non-Small Cell Lung Cancer (NSCLC). METHODS: We performed meta-analysis including trials comparing EGFR-TKIs, Anaplastic Lymphoma Kinase (ALK) inhibitors or Immune Checkpoint Inhibitors (ICIs) against chemotherapy in NSCLC. The Progression-Free Survival (PFS)-Hazard Ratios (HRs) of two groups served as the index and we used random effects to pool outcomes. RESULTS AND DISCUSSION: Twenty randomized trials were selected. Compared with chemotherapy, treatment with EGFR-TKIs had similar benefit in never-smokers (PFS: HR = 0.46, 95% CI 0.30 to 0.69) and smokers (PFS: HR = 0.68, 95% CI 0.50 to 0.91; p = 0.135) while non-smokers (PFS: HR = 0.32, 95% CI 0.23 to 0.44) had better benefit from first-line EGFR-TKIs than smokers (PFS: HR = 0.54, 95% CI 0.41 to 0.71; p = 0.02). Treatment with ALK inhibitors had similar benefits in never-smokers (PFS: HR = 0.43, 95% CI 0.35 to 0.53) and smokers (PFS: HR = 0.56, 95% CI 0.44 to 0.71; p = 0.406). The benefit of ICIs in smokers (PFS: HR = 0.79, 95% CI 0.64 to 0.98) was significantly greater than never-smokers (PFS: HR = 1.81, 95% CI 1.27 to 2.57; p = 0.004). WHAT IS NEW AND CONCLUSION: Smoking status is an important clinical predictor of therapy in NSCLC. Never-smokers and smokers have similar benefit with EGFR-TKIs therapy compared with chemotherapy, while never-smokers have greater benefit after first-line EGFR-TKIs therapy. There was similar benefit in never-smokers and smokers when using ALK inhibitors over chemotherapy. Additionally, ICIs treatment over chemotherapy leads to more favourable PFS in smokers both in first-line and second-line settings.

Antibiotic use and irrational antibiotic prescriptions in 66 primary healthcare institutions in Beijing City, China, 2015-2018.

OBJECTIVES: To identify the patterns of antibiotic use and irrational antibiotic prescriptions in primary healthcare institutions (PHIs) in Dongcheng District of Beijing, China. MATERIALS AND METHODS: All primary healthcare institutions (7 community healthcare centres and 59 community healthcare stations in total) in Dongcheng District were included in the study. Prescription data from January 2015 to December 2018 was derived from the Beijing Prescription Reviewing System of Primary healthcare institutions and analysed retrospectively. The antibiotic prescription rate was calculated and cases of irrational antibiotic prescriptions were identified. RESULTS: We extracted 11,166,905 prescriptions from the database. Only 189,962 prescriptions were included in the study, among which 9167 (4.8%) contained antibiotics. The antibiotic prescription rate fell from 5.2% in 2015 to 4.1% in 2018 while irrational antibiotic prescription rate increased from 10.4 to 11.8%. Acute Bronchitis was the most prevalent diagnosis (17.6%) for antibiotic prescriptions, followed by Unspecified Acute Respiratory Tract Infection (14.4%), Acute Tonsillitis (9.9%), and Urinary Tract Infection (6.4%). Around 10% of the prescriptions for the top 7 diagnoses identified were rated as irrational. Cephalosporins, fluoroquinolones, and macrolides were the most prescribed antibiotics, which accounted for 89.3% of all antibiotic prescriptions. Of all the antibiotic prescriptions, 7531 were reviewed, among which 939 (12.5%) were rated as irrational because of antibiotic use. Among all the irrational prescriptions, prescriptions with inappropriate antibiotic use and dosage accounted for the majority (54.4%). CONCLUSION: Although a relatively low level of antibiotic utilization was found in PHIs in Dongcheng District of Beijing, the utilization patterns differed considerably from developed countries and irrational prescriptions remained. Considering the imbalanced allocation of medical resources between primary healthcare setting and secondary and tertiary hospitals, there need to be more efforts invested in regions with different levels of economic development.

Potentially inappropriate medications among elderly patients in community healthcare institutions in Beijing, China.

PURPOSE: To evaluate potentially inappropriate medications (PIMs) prevalence and predictors in community healthcare institutions (CHIs) for the elderly. METHODS: We conducted a retrospective observational study, deriving data of patients aged ≥60 from 66 CHIs in Beijing, 2014-2018. The system of Criteria of PIM for Older Adults in China was applied to identify PIMs. The primary outcome was the prevalence of visits with at least one PIM; secondary outcomes were the frequency and rate per thousand visits of specific PIMs. We used descriptive analysis and generalized linear models to analyzed PIMs and the predictors, and marginal effects methods were applied to estimate the mean adjusted PIMs prevalence. RESULTS: Overall, 4 528 884 elderly patient visits from 2014 to 2018 were eligible for inclusion. A total of 719 757 PIMs were detected, with 14.1% of the visits contained at least one PIM. PIM prevalence was significantly correlated with age, number of prescribed medications and number of diagnoses. Overall, 6.0 per thousand elderly patients in CHIs were exposed to at least one high-risk PIM, while 117.5 per thousand were exposed to at least one low-risk PIM. In 2018, 20% of GPs were responsible for more than half of overall PIM visits. CONCLUSION: Prescribing of PIMs for older adults is common in CHIs in China, especially for patients who are aged, having multiple medications and diagnostic diseases. Strategies should be developed to enhance prescribing quality for geriatric patients, with special targeting of doctors responsible for a high number of PIMs.

The impact of global budget on expenditure, service volume, and quality of care among patients with pneumonia in a secondary hospital in China: a retrospective study.

BACKGROUND: The Chinese government has begun to dampen the growth of health expenditure by implementing Global Budgets (GB). Concerns were raised about whether reductions in expenditure would lead to a deterioration of quality of care. This paper aims to evaluate the impact of GB on health expenditure, service volume and quality of care among Chinese pneumonia patients. METHODS: A secondary hospital that replaced Fee-For-Service (FFS) with GB in China in 2016 was sampled. We used daily expenditure to assess health expenditure; monthly admission, length of stay (LOS), number of drugs per record and record containing antibiotics to evaluate service volume; record with multiple antibiotics and readmission to assess quality of care. Descriptive analyses were adopted to evaluate changes after the reform, logistic regression and multivariable linear regressions were used to analyze changes associated with the reform. RESULTS: In 2015 and 2016, 3400 admissions from 3173 inpatients and 2342 admissions from 2246 inpatients were admitted, respectively. According to regression analyses, daily expenditure, LOS, readmission, and records with multiple antibiotic usages significantly declined after the reform. However, no significant relation was observed between GB and the number of drugs per record or record containing antibiotics. CONCLUSIONS: When compared with FFS, GB can curtail health expenditure and improve quality of care. As far as service volume was concerned, LOS and monthly admission declined, while number of drugs per record and record containing antibiotics were not affected.

Medical insurance and healthcare utilization among the middle-aged and elderly in China: evidence from the China health and retirement longitudinal study 2011, 2013 and 2015.

BACKGROUND: In response to China's rapidly aging population and increasing healthcare service demands, the Chinese government is developing a universal medical insurance system. This study aimed to assess healthcare utilization patterns and analyze the impacts of medical insurance schemes on healthcare utilization among the middle-aged and elderly in China. METHODS: Data was extracted from the China Health and Retirement Longitudinal Study in 2011, 2013 and 2015. Healthcare utilization was measured by outpatient and inpatient service utilization. Univariate analysis was deployed to examine the impacts of different medical insurance schemes on healthcare utilization. The factors associated with healthcare utilization were estimated using a random-effects logistic regression model. RESULTS: During the study period, the number of individuals involved was 17,250, 18,195 and 19,842, respectively. The proportion of individuals who received outpatient service was 18.6, 20.7 and 18.7% and those who used inpatient service was 9.6, 13.8 and 14.3%, respectively. We identified that medical insurance was a major protective factor for improving healthcare utilization but different medical insurance schemes exerted various impacts on the middle-aged and the elderly. CONCLUSIONS: Despite the growing population coverage, the Chinese government should make every effort to bridge the gap among people with different medical insurance schemes. Further evaluation is needed to assess whether the expanded medical insurance schemes could protect the middle-aged and elderly households from catastrophic health expenditure.

Safety of medication use during pregnancy in mainland China: based on a national health insurance database in 2015.

BACKGROUND: Medication safety during pregnancy has drawn global attention, little of which has been reported about the Chinese population. This study aims to describe patterns and risks of medication use among pregnant women in mainland China with reference to the U.S. Food and Drug Administration (FDA) pregnancy risk category. METHODS: Hospital diagnostic and drug dispensing information of a national representative sample of basic medical insurance (BMI) beneficiaries was obtained from the China Health Insurance Association (CHIRA) database in 2015. Prevalence of use and number of medicines involved in each risk category were calculated. Most commonly used medicines from each risk category were illustrated. Factors associated with the use of category D/X medicines were evaluated through multiple logistic regression. RESULTS: Out of 11,373 women who had singleton deliveries in 2015, there were 2896 women with records covering their entire pregnancies, 5377, and 7946 women with records through the 2nd, and the 3rd trimester, respectively. It was found that 11.1% pregnant women used at least one medication and a total of 321 medications had been used during pregnancy. Most pregnant women used medicines which were classified FDA category C (66.2%), followed by category B (57.8%), category A (16.8%), category X (7.5%) and category D (5.0%). The most commonly used medicines from category D and X were anxiolytics and hormonal preparations respectively. Women who were from mid-western area (p = 0.045) or used four or more medications (p < 0.001) were more likely to use category D/X medicines. CONCLUSIONS: This study revealed that about one in ten pregnant women used at least one medication during pregnancy in China and a significant number of them used FDA Category D or X medicines. The usage patterns identified in the present study indicate that sub-optimal medicine use might exist warranting further evaluation and intervention in future studies. More efforts are needed to uncover the safety concerns about medication use during pregnancy and improve current information system for clinical practice.

Comparisons of diabetic retinopathy events associated with glucose-lowering drugs in patients with type 2 diabetes mellitus: A network meta-analysis.

AIM: To assess the comparative effects of glucose-lowering drugs (GLDs) on the risk of diabetic retinopathy (DR) in patients with type 2 diabetes mellitus (T2DM). METHODS: We systematically searched Cochrane Central Register of Controlled Trials, PUBMED and EMBASE from inception to January 17, 2017 to identify randomized controlled trials (RCTs) that reported DR events among T2DM patients receiving any GLD. Random-effects pairwise and network meta-analyses were performed to calculate odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: A total of 37 independent RCTs with 1806 DR events among 100 928 patients with T2DM were included. The mean duration of diabetes was 8.7 years and mean baseline HbA1c was 8.2% (SD, 0.5%). Our network meta-analysis found that DPP-4i (OR, 1.20; 95% CI, 0.87-1.65), GLP-1RA (OR, 1.19; 95% CI, 0.94-1.52) and SGLT2 inhibitors (OR, 0.79; 95% CI, 0.49-1.28) were not associated with a higher risk of DR than placebo; however, a significantly increased risk of DR was associated with DPP-4i in the pairwise meta-analysis (OR, 1.27; 95% CI, 1.05-1.53). Sulfonylureas, on the other hand, were associated with a significantly increased risk of DR compared to placebo (OR, 1.67; 95% CI, 1.01-2.76). CONCLUSIONS: Current evidence indicates that the association between DPP-4i, GLP-1RA or SGLT2 inhibitors and risk of DR remains uncertain in patients with T2DM. Some evidence suggests that sulfonylureas may be associated with increased risk of DR. However, given that DR events were not systematically assessed, these effects should be explored further in large-scale, well-designed studies.

A survey of availability, price and affordability of essential medicines from 2011 to 2016 in Chinese secondary and tertiary hospitals.

BACKGROUND: Essential medicines are those drugs that satisfy the priority health care needs of the population and help with functioning healthcare systems. Although many countries have formulated an essential medicine list, almost half of the global population still lack regular access to essential medicines. Research about the initiation of National Essential Medicines Policy in Chinese secondary and tertiary hospitals is inadequate, and the long-term effect on access after the reform is still unknown. This study's objective was to investigate the access to essential medicines in mainland China's secondary and tertiary hospitals. METHODS: Data on the access to 30 essential medicines from China's National Essential Medicine List were obtained from China Medicine Economic Information database covering 396 secondary hospitals and 763 tertiary hospitals. We improved the standard methodology developed by the World Health Organization and the Health Action International to measure the availability, median price ratio (MPR) and the incidence of catastrophic drug expenditure (CDE). RESULTS: Five essential medicines had > 50% availability and the nationwide availability kept steady; availability of drugs in eastern regions of China was significantly higher than the central and western regions. The median MPR of 30 drugs nationwide kept steady approximately 5; MPR of drugs in the eastern regions was significantly higher than the central and western regions and the ratio of MPR of innovator brands to generics increased from 3.66 to 6.32 during the study period. The incidence of CDE caused by essential medicines decreased from 2011 to 2014; brand name medicines were more likely to cause CDE than generics and rural patients have a greater tendency to fall into CDE. CONCLUSIONS: After the implementation of National Essential Medicines Policy, the MPR of essential medicines was well controlled and became more affordable in the context of steady availability. This has highlighted the problems associated with region disparity and inequity between rural and urban areas in the delivery of essential medicines and sustainable mechanisms are needed to deepen the National Essential Medicines Policy in mainland China.

The effect of the implementation of low price medicine policy on medicine price in China: A retrospective study.

In an effort to relieve the pressure of drug shortages, the Chinese government implemented Low-price Medicines (LPM) policy to raise the price cap in July 2014. The purpose of this study is to examine the effect of the implementation of this policy on drug price in China. Price data of 491 LPM, including 218 low-price chemical medicines (LPCM) and 273 low-price traditional Chinese medicines (LPTCM), were collected from 699 hospitals. We used interrupted time series design to identify the variation of monthly Laspeyres Indexes (LI) and Paasche Indexes (PI) for LPM, LPCM, and LPTCM. The result demonstrated that although LPM expenditures increased, the proportion of LPM expenditures accounting for all medicine expenditures fell from 3.6% to 3.2%. After the implementation of LPM policy, there was a significant increasing trend in LPM-PI, LPCM-PI, and LPTCM-PI. The trend in LPM-LI and LPCM-LI was found from descending to rising. However, for LPTCM, the trend in the LI remained to decrease after the policy implementation. Despite the LPM policy had an increasing impact on the LPM drug price, the proportion of LPM expenditures accounting for all medicine expenditures did not increase. More efforts are needed in the future to promote the rational drug use in China.